Pregabalin-AFT

What it is

Pregabalin-AFT is an oral liquid solution containing 20 mg of pregabalin per millilitre. The product is a clear colourless liquid. Pregabalin is an analogue of the neurotransmitter gamma-aminobutyric acid (GABA) with analgesic and anticonvulsant activity.

Approved indications

— Neuropathic pain in adults. — Adjunctive therapy in adults with partial seizures with or without secondary generalisation.

Dosing overview

The dose range is 150 to 600 mg (7.5 to 30 ml) per day given in two divided doses. Pregabalin-AFT may be taken with or without food. If pregabalin has to be discontinued it is recommended this should be done gradually over a minimum of 1 week.

Key safety warnings

Pregabalin-AFT is a potential drug of misuse, abuse, and dependence. It poses risks of misuse, abuse and dependence which can lead to overdose and death especially when used concomitantly with opioids and other CNS depressants. Patients' risk of misuse, abuse or dependence should be assessed before prescribing and patients monitored regularly during treatment, particularly amongst those with current or past misuse, abuse or dependence of opioids and/or benzodiazepines. Pregabalin-AFT causes dizziness and somnolence, which generally begin shortly after initiation and occur more frequently at higher doses. Antiepileptic drugs including pregabalin increase the risk of suicidal thoughts or behaviour in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behaviour, and/or any unusual changes in mood or behaviour. Concomitant use of opioids may result in severe sedation, respiratory depression, coma, and death. Dosages and durations of Pregabalin-AFT should be limited to the minimum required to achieve desired therapeutic effect and patients monitored for signs and symptoms of respiratory depression and sedation. There have been reports of severe respiratory depression in relation to pregabalin use. Patients with compromised respiratory function, respiratory or neurological disease, renal impairment, concomitant use of CNS depressants and the elderly may be at higher risk of experiencing this severe adverse reaction.

Contraindications

Pregabalin-AFT is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients. Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

PBS listing

No information on PBS listing for Pregabalin-AFT is available in the provided documents.

Regulatory history

Pregabalin-AFT (20 mg/mL oral liquid solution) was first registered on the ARTG on 16 September 2020. A PBAC outcome in November 2021 resulted in deferral for the neuropathic pain indication.